SGN-00101 Vaccine in Treating Human Papillomavirus in Patients Who Have Abnormal Cervical Cells (NCT00091130) | Clinical Trial Compass
CompletedPhase 2
SGN-00101 Vaccine in Treating Human Papillomavirus in Patients Who Have Abnormal Cervical Cells
United States139 participantsStarted 2004-09
Plain-language summary
This randomized phase II trial is studying how well SGN-00101 vaccine works compared to a placebo in treating human papillomavirus and preventing cervical cancer in patients with abnormal cervical cells. Vaccines, such as SGN-00101, may make the body build an immune response to kill human papillomavirus and abnormal cervical cells and may be effective in preventing cervical cancer
Who can participate
Age range
18 Years – 50 Years
Sex
FEMALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Meets criteria for 1 of the following groups:
* Prospective group, meeting the following criteria:
* Evidence of atypical squamous cells of undetermined significance (ASCUS) or low-grade squamous intraepithelial lesions (LSIL) by Pap test
* Human papillomavirus (HPV)-16-positive by polymerase chain reaction (PCR) and PGMY09/PGMY11 oligonucleotide primers viral load assay
* Medical records-based group, meeting the following criteria:
* Medical-record evidence of ASCUS or LSIL by Pap test within the past 6-12 months
* Meets 1 of the following criteria:
* Liquid-cytology findings of ASCUS or LSIL
* Colposcopic evidence of a LSIL by the Reid Index score of 1-5
* Historically persistent HPV-16-infection by PCR and HPV reverse transcription (RT)-PCR
* No evidence of high-grade squamous intraepithelial lesions (HSIL) by colposcopy (Reid Index ≥ 6)
* Reports no sex partner change since last index Pap screening test
* Specimen-based group, meeting the following criteria:
* Medical-record evidence of ASCUS or LSIL by Pap test within the past 6-12 months
* Liquid-based cytology specimen available
* Meets 1 of the following criteria:
* Liquid-cytology findings of ASCUS or LSIL
* Colposcopic evidence of a LSIL by the Reid Index score of 1-5
* Historically persistent HPV-16-infection by PCR and, where measurable, HPV RT-PCR showing no greater than 3-fold reduction over the index liquid…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
HPV-16 viral load
Timeframe: 6 months
2
Natural history of HPV 16 viral load
Timeframe: Baseline
3
Natural history of HPV 16 viral load
Timeframe: 3 months
4
Natural history of HPV 16 viral load
Timeframe: 6 months
5
Regression or non-regression of the cellular atypia